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University is a place where researchers have the freedom to discover new knowledge and to innovate. Hence, in line with this, academicians and researchers are the pillar of strength of our foundation in the University of Malaya (UM).

Self-Management Intervention for Malaysian Women with Breast Cancer: Enabling Quality of Life and Participation

A. Introduction
Breast cancer is the leading form of cancer for women {Globocan, 2002}. Survivor rates are much better than other types of common cancer such as lung or colon cancers {Jemal, 2002}. Increasing survivorship is contributed by a declining rate of mortality {Mettlin, 1999; Greenlee, 2000}, which is due to early detection and improved therapy. Today, breast cancer is increasingly seen as a chronic illness (Fallowfield, 2004). Women diagnosed with breast cancer face very stressful life events {Faulkner, 1994 McDaniel, 1995; Carver, 1993}; aggravated by the uncertainties of recurrence which continue beyond medical treatments {Klee, 2000}.

Effective prevention and management of significant morbidity from the illness and its treatment, which reduces quality of life has taken on increasing importance {Erickson, 2001}. Today, women with breast cancer, like any other chronic illness, have many years to benefit from self-management strategies to enhance quality of life.

B. General and Specific Objectives
This is a 3-phase study.
Null hypotheses of the main study are:

HO/ /=At completion of the intervention, and at 6 weeks follow up, there will be no differences, between the intervention and control groups, on quality of life (SF36), mental distress (DASS) and perceived participation (IPA).

HO =At completion of the intervention, and at 6 weeks follow up, there will be no difference, between the intervention and control, in terms of Self-efficacy and Proactive Coping

OUTLINE OF RESEARCH PLAN

Design and Setting :
This time series clinical trial was conducted at University Malaya Medical Centre (UMMC) between the 2004 -2008 period. The entire study was based on the UK Medical Research Council (2000)’s framework for developing complex intervention, and to demonstrate increasing evidence. The Phase 1 was conducted in 2004 and involved reviews of current intervention for breast cancer and a qualitative study on unmet needs of patient self management amongst women with breast cancer. Phase 2 involved modeling and designing a 4-week intervention which was piloted on a small group of women. Phase 3 or the main study was conducted in 2006 till 2008 as a clinical controlled trial. Baseline data was collected before the intervention and upon completion of the 4 week intervention. This was follow-up with another measurement at 4-weeks post treatment.

Tools:
The primary outcome measures are Quality of life, mental distress and perceived participation. The secondary outcomes are the three specific self-efficacy measures and the proactive coping.

Ethic:
Ethical approvals were obtained from The Human Research Ethics Committee of Curtin University, and the Research Ethics Committee of UMMC, and The Ministry Of Health before recruiting study participants.

PARTICIPANTS and RECRUITMENT

Participants will be recruited through public advertisement and from physician referral to the Breast clinics. Interested participants will then contact the researcher. Eligible and interested survivors will be followed up with a package, consisting of a cover letter, consent form, and baseline questionnaire.

Inclusion criteria were: i) more than 18 years of age, ii) confirmed by physicians a diagnosis of Stage 1-III (with no evidence of recurrence), iii) completed surgery, iv)may or may not be undergoing chemotherapy and/or radiotherapy, iv) may or may not be undergoing hormonal (or other endocrine therapy), v) can read and understand English, and vi) give informed-consent.

Exclusion criteria are i)marked cognitive impairment or learning disabilities (through
observation/ interview) and ii) has other form of medical problem interfering with participation and attendance (from self report).

FUNDING

The study was funded by MAKNA (M) and UM’s fundamental Research grant and with the Australian’s International Postgraduate Research Scholarship Award.